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Phase II Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Gustave Roussy
ClinicalTrials.gov Identifier:
NCT00147160
First received: September 6, 2005
Last updated: April 10, 2012
Last verified: September 2006
History of Changes
  Purpose

The purpose of this study is to determine whether the combination of Temozolomide and Cisplatinum is effective in the treatment of malignant glial tumours of children and adolescents


Condition Intervention Phase
Glioma
 Drug: Temozolomide, Cisplatinum
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of the Combination of Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents at Diagnosis or in Relapse

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Institut Gustave Roussy:

Primary Outcome Measures:
  • Radiological response after two courses of Temozolomide-Cisplatinum

Secondary Outcome Measures:
  • Progression-free survival
  • Health status and quality of life
  • Toxicity

Estimated Enrollment: 87
Study Start Date: October 2003
Study Completion Date: December 2007
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   4 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age from 4th birthday and younger than 21st birthday
  • Histologically documented malignant glial tumour (WHO classification grade III and IV) : astrocytoma, oligodendroglioma, oligoastrocytoma and mixed tumours
  • Measurable and evaluable disease by the imaging criteria (MRI)
  • Patient not previously treated by either of the two drugs

Exclusion Criteria:

  • Malignant brain stem tumours are excluded
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00147160

Locations
France
Institut Gustave-Roussy
Villejuif, France, 94805
United Kingdom
Bristol Royal Hospital for Children
Bristol, United Kingdom, BS2 8BJ
Sponsors and Collaborators
Institut Gustave Roussy
Investigators
Principal Investigator: Jacques Grill, MD, PhD Institut Gustave Roussy
  More Information

No publications provided

Responsible Party: Institut Gustave Roussy
ClinicalTrials.gov Identifier: NCT00147160     History of Changes
Other Study ID Numbers: CISTEM2, CSET-2002/978
Study First Received: September 6, 2005
Last Updated: April 10, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Cisplatin
 Dacarbazine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013